Multi-Lumen Medical Devices and Methods of Manufacturing Same

ABSTRACT

A method of manufacturing a catheter shaft includes extruding an inner polymeric layer having a main lumen and two or more side lumens spaced about the main lumen; forming an outer polymeric layer about the inner polymeric layer; and inserting at least one elongate member, such as a wire, through each side lumen of the inner polymeric layer. The side lumens are less than about ⅕ the size of the main lumen. The method may further include the step of forming a braided layer between the inner polymeric layer and the outer polymeric layer. In an alternate embodiment, the method includes co-extruding an inner polymeric layer and a multi-lumen layer, the multi-lumen layer having two or more side lumens; forming an outer polymeric layer about the multi-lumen layer; and inserting at least one elongate member through each side lumen. Catheter assemblies made according to the described methods are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/400,663, filed 6 Jan. 2017, now pending, which is a division of U.S.application Ser. No. 12/346,396, filed 30 Dec. 2008, now abandoned,which are hereby incorporated by reference as though fully set forthherein.

BACKGROUND OF THE INVENTION a. Field of the Invention

The present invention pertains generally to electrophysiological deviceshaving multiple lumens and methods for manufacturing multi-lumenelectrophysiological devices. More particularly, the invention isdirected to catheters and introducers and methods for manufacturingcatheters and introducers having multiple, integrally-formed orco-extruded side lumens for enclosing elongate members, such as steeringwires and electrical wires.

b. Background Art

Catheters are used for an ever-growing number of procedures. Forexample, catheters are used for diagnostic, therapeutic, and ablativeprocedures, to name just a few examples. Typically, the catheter ismanipulated through a patient's vasculature and to the intended site,for example, a site within the patient's heart. The catheter typicallycarries one or more electrodes, which may be used for ablation,diagnosis, or the like.

Many catheters include one or more wires, for example, pull wires forsteering and deflecting the catheter and/or electrical wires forenergizing electrodes or other energy delivery or diagnostic elements.In some catheters, the wires are enclosed in small, polymeric liners orjackets that surround a main liner or jacket. The small jackets aremanufactured separately from the main jacket and are subsequently gluedalong the length of the main jacket. The gluing process istime-consuming and can be inefficient. The small jackets must be gluedsubstantially straight along the length of the main jacket; otherwise,steerable devices will not deflect properly. Also, the process becomesmore time-consuming for devices using greater numbers of wires becausegreater numbers of small jackets must be glued along the length of themain jacket.

Accordingly, there is a growing need for improved catheters and improvedmethods for manufacturing catheters having liners or jackets thatenclose the various wires to eliminate the time-consuming andinefficient gluing process.

BRIEF SUMMARY OF THE INVENTION

The present invention provides for medical devices and methods ofmanufacturing medical devices having multiple, integrally-formed sidelumens enclosing elongate members, such as steering wires and electricalwires. The present invention also provides for medical devices andmethods of manufacturing medical devices having a multi-lumen layerco-extruded with an inner layer.

An objective of the present invention is to provide methods ofmanufacturing a catheter assembly having multiple side lumensintegrally-formed with a main lumen.

Another object of the invention is to provide methods of manufacturing acatheter assembly having an extruded polymer layer comprising a mainlumen and multiple side lumens arranged about the main lumen.

Still another object of the present invention is to provide methods ofmanufacturing a catheter assembly having an inner polymeric layerco-extruded with a multi-lumen layer.

Yet another object of the present invention is to provide medicaldevices manufactured by the methods described herein.

A method of manufacturing a catheter assembly includes the steps ofextruding an inner polymeric layer, the inner polymeric layer defining amain lumen having an inner surface and an outer surface and furtherdefining two or more side lumens spaced about the outer surface of themain lumen. In one aspect, a size of the side lumens is less than about⅕ to about 1/16 a size of the main lumen. The method further includesforming an outer polymeric layer disposed about the inner polymericlayer and inserting at least one elongate member through each side lumenof the inner polymeric layer. The elongate member may be a wire, such asa pull wire or an electrical wire.

The method may optionally include the step of forming a braided layerbetween the inner polymeric layer and the outer polymeric layer. Theinner polymeric layer, the braided layer and the outer polymeric layermay be heated to bond the inner polymeric layer, the braided layer andthe outer polymeric layers together. The inner polymeric layer may bemade of polytetrafluoroethylene. The side lumens may be spacedsymmetrically about the outer surface of the main lumen or may be spacedin any other orientation. In one aspect, the inner polymeric layerincludes about 2-16 side lumens.

In another embodiment of the present invention, a method ofmanufacturing a catheter assembly includes co-extruding an innerpolymeric layer and a multi-lumen layer. The inner polymeric layerincludes an inner surface defining a main lumen and an outer surface,and the multi-lumen layer includes two or more side walls, each sidewall defining a side lumen. The method further includes forming an outerpolymeric layer about the multi-lumen layer and inserting at least oneelongate member through each side lumen. The method may optionallyinclude a step of forming a braided layer between the multi-lumen layerand the outer polymeric layer. The inner polymeric layer, themulti-lumen layer, the braided layer and the outer polymeric layer mayalso be heated to bond the layers together.

The inner polymeric layer and the multi-lumen layer may be made of thesame or different materials. In one aspect, the inner polymeric layerand the multi-lumen layer are made of polytetrafluoroethylene. A size ofthe side lumens may be less than about ⅕ to about 1/16 a size of themain lumen. The multi-lumen layer may include about 2-16 side lumens,which may be spaced symmetrically about the outer surface of the mainlumen, or in any other orientation. The elongate member may be a wire,such as a pull wire or an electrical wire.

In yet another aspect of the present invention, a catheter assemblyincludes an inner extruded polymeric layer and an outer polymeric layerdisposed about the inner extruded polymeric layer. The inner extrudedpolymeric layer includes a main lumen having an inner surface and anouter surface and two or more side lumens spaced about the outer surfaceof the main lumen. The device further includes at least one elongatemember extending through one of the side lumens. In one embodiment, abraided layer may be disposed between the inner extruded polymeric layerand the outer polymeric layer. In one aspect, a size of the side lumensmay be less than about ⅕ to about 1/16 a size of the main lumen. Theside lumens may be spaced symmetrically about the outer surface of themain lumen, or in a non-symmetrical orientation. The inner extrudedpolymeric layer may include about 2-16 side lumens. The inner extrudedpolymeric layer may be made of polytetrafluoroethylene. In oneembodiment, the elongate member may be a wire, such as a pull wire or anelectrical wire.

In still another aspect of the present invention, a catheter assemblyincludes an inner polymeric layer having an inner surface defining amain lumen and having an outer surface and a multi-lumen layer disposedabout the outer surface of the inner polymeric layer. The multi-lumenlayer includes two or more side walls, each side wall defining a sidelumen. The multi-lumen layer and the inner polymeric layer areco-extruded. The catheter shaft further includes an outer polymericlayer disposed about the multi-lumen layer and at least one elongatemember extending through one of the side lumens. In one embodiment, abraided layer may be disposed between the multi-lumen layer and theouter polymeric layer. A size of the side lumens may be less than about⅕ to about 1/16 a size of the main lumen. The multi-lumen layer mayinclude about 2-16 side lumens. The side lumens may spaced symmetricallyabout the outer surface of the main lumen or in a non-symmetricalorientation. In one embodiment, the elongate member may be a wire, suchas a pull wire or an electrical wire.

An advantage of providing medical devices having multiple,integrally-formed lumens for enclosing elongate members is a shortermanufacturing process.

Another advantage of providing medical devices having multiple,integrally-formed lumens for carrying elongate members is a moreefficient manufacturing process and fewer product defects.

The foregoing and other aspects, features, details, utilities, andadvantages of the present invention will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a catheter according to an embodiment ofthe present invention.

FIGS. 2A-D depict cross-sectional views of various embodiments of aninner layer of a catheter assembly according to the invention.

FIG. 3 is a cross-sectional view of a catheter assembly having an innerlayer as depicted in FIG. 2A, prior to the application of heat to meltprocess the outer layer.

FIG. 4 depicts a cross-sectional view of a catheter assembly having aninner layer as depicted in FIG. 2A, after the application of heat tomelt process the outer layer.

FIG. 5 is a cross-sectional view of a catheter assembly having multipleintegrally-formed side lumens with pull wires and electrical wiresextending through the side lumens.

FIG. 6 depicts a cross-sectional view of an inner layer of a catheterassembly according to another embodiment of the present invention.

FIG. 7 illustrates a cross-sectional view of a catheter assembly havinga multi-lumen layer as depicted in FIG. 6, prior to the application ofheat to melt process the outer layer.

FIG. 8 is a cross-sectional view of a catheter assembly having amulti-lumen layer as depicted in FIG. 6, after the application of heatto melt process the outer layer.

FIG. 9 depicts is a cross-sectional view of a catheter assembly having aco-extruded multi-lumen layer with pull wires and electrical wiresextending through the side lumens of the multi-lumen layer.

DETAILED DESCRIPTION OF THE INVENTION

Disclosed herein are medical devices and methods of manufacturingmedical devices, for example catheters and introducers, having multipleside lumens integrally-formed or co-extruded with a main lumen. The sidelumens enclose elongate members, for example steering wires andelectrical wires. The present invention provides catheters and methodsof manufacturing catheters suitable for use in the human vasculature forknown medical procedures, such as cardiac diagnostic and therapeuticprocedures including, without limitation, electrophysiological mappingand cardiac ablation. It is contemplated, however, that the describedfeatures may be incorporated into any number of catheters or otherdevices, such as steerable introducers, as would be appreciated by oneof ordinary skill in the art.

FIG. 1 is a perspective view of one embodiment of a catheter 12 of thepresent invention. Catheter 12 has a proximal portion 16 and a distalportion 14.

One method of manufacturing a catheter 12 according to the presentinvention will be described with reference to FIGS. 3-5. As they areassembled, the catheter components will be collectively referred to as acatheter assembly.

FIG. 3 displays a cross-section of a catheter assembly 12 prior tomelt-processing of the layers by heating. A mandrel 10 may be the firstcomponent during manufacture of the catheter assembly 12. The mandrel 10may be round in cross-section and may be from about 6 inches to about 4feet in length. The mandrel 10 has a distal end and a proximal end. Afirst or inner polymeric layer 20 is placed on mandrel 10. Innerpolymeric layer 20 may be knotted at one end (e.g. the distal end) andthen fed onto mandrel 10.

Several embodiments of the inner polymeric layer 20 are depicted inFIGS. 2A-D. In general, the inner polymeric layer 20 includes a mainlumen 11 having an inner surface 13 and an outer surface 15. The innerpolymeric layer 20 further includes multiple integrally-formed sidelumens 30 spaced about the outer surface 15 of the main lumen 11. As aperson of skill in the art will understand, however, theintegrally-formed side lumens 30 may alternatively be spaced about theinner surface 13 of the main lumen 11. The side lumens 30 may be spacedsymmetrically about the main lumen 11 (see, for example, FIG. 2A), butneed not be in a symmetrical orientation (see, for example, FIG. 2C).

The inner polymeric layer 20 is an extruded polymer. In one embodiment,the inner polymeric layer 20 is an extruded polytetrafluoroethylene(PTFE) tubing, such as Teflon® brand tubing, which is availablecommercially. The inner polymeric layer 20 may optionally be chemicallyetched to provide better adhesion during melt processing. As a person ofskill in the art will appreciate, the inner polymeric layer 20 may beextruded from other melt processable polymers, including, withoutlimitation, polyetheretherketone (PEEK), polyimides, polyesters,polyamides, polysulfones, polyketones, other fluoropolymers, and thelike. In one aspect, the inner polymeric layer 20 uses PTFE as a coatingover another polymer material, for example, a polyimide extrusion linedwith PTFE. In another aspect, the inner polymeric layer 20 is made of amaterial with a melting temperature higher than that of an outer layer50, which will be further described below, such that the inner polymericlayer 20 will withstand melt processing of the outer layer 50.

In one aspect, the side lumens 30 are about ⅕ the size of the main lumen11 (see, for example, FIGS. 2A-C). In another aspect, the side lumens 30may be about 1/16 the size of the main lumen 11 or smaller (see, forexample, FIG. 2D). The side lumens 30 are sized to conformably encloseat least one elongate member, for example a pull wire or an electricalwire, while facilitating at least some movement of the elongate memberwithin the side lumen 30 and at the same time minimizing friction causedby movement of the elongate member within the side lumen 30. A person ofskill in the art will appreciate that the side lumens 30 can be sizedand shaped to accommodate elongate member of various dimensions andcross-sectional configurations. The side lumens 30 need not have thesame shape as the cross-section of the elongate members that theyencase. The side lumens 30 may be round, oval, rectangular, or anotherlike shape.

As shown in FIG. 2B, inner polymeric layer 20 may include two sidelumens 30. The side lumens 30 may be spaced in an opposing orientationas shown in FIG. 2B, or may be spaced in any other orientation about thecircumference of the main lumen 11. For example, the side lumens 30 maybe immediately adjacent one another or may be spaced about thecircumference of the main lumen 11 by about 45 degrees, by about 90degrees or more. In another aspect, the inner polymeric layer 20includes more than two side lumens 30. For example, the inner polymericlayer 20 may include up to 8 side lumens, up to 16 side lumens or morethan 16 side lumens (see, for example, FIGS. 2A-D). As a person of skillin the art will understand, the inner polymeric layer 20 can be modifiedto accommodate various numbers of elongate members having variousdimensions and cross-sectional configurations.

As further shown in FIGS. 2A-2D, in one aspect, the inner polymericlayer 20 has a scalloped or ribbed profile. This structure isparticularly advantageous for steerable devices because it providesgreater flexibility. The amount of space between adjacent side lumens 30may vary depending on the number of side lumens present and the locationof the side lumens about the main lumen 11.

Referring again to FIG. 3, the extruded inner polymeric layer 20 isplaced on the mandrel 10. A small diameter mandrel or set-up wire 90 maybe placed within the side lumens 30 to maintain the integrity of theside lumens during processing. Alternatively, a pull wire may beinserted through one or more of the side lumens 30 in lieu of a smalldiameter mandrel 90. In still other embodiments, the side lumens 30 maybe maintained during processing via the use of a pressurized fluid asdescribed in U.S. patent publication no. US 2006/0151923, which isincorporated herein by reference in its entirety.

An outer polymeric layer 50 is then placed over the inner polymericlayer 20. The outer polymeric layer 50 may be made of either single ormultiple sections of tubing that may be either butted together oroverlapped with each other. In one aspect, the outer polymeric layer 50is made of a melt-processable polymer, such as polyether block amides,nylon, polyethylene and other thermoplastic elastomers. For example, theouter polymeric layer 50 may be made of Pebax®, polyether block amidemade by Arkema, Inc. Pebax® of various durometers may be used,including, without limitation, Pebax 20D to Pebax 72D. The outerpolymeric layer 50 may also comprise more than one layer or segment,including for example two or more tubes of a melt processing polymerarranged to abut one another and/or to overlap one another.

Optionally, a braided layer 40 may be placed over the inner polymericlayer 20 before the outer polymeric layer 50 is applied. The braidedlayer 40 may be formed of stainless steel wire, including, for example,0.003″ high tensile stainless steel wire. The braided layer 40 may alsobe formed of a metal alloy, for example, a copper alloy. The braidedlayer 40 may be formed in a standard braid pattern and density, forexample, about 16 wires at about 45 to about 60 picks per inch (“PPI”)density. Alternatively, a braid may be used that is characterized by avarying braid density. For example, the braided layer 40 may becharacterized by a first braid density at the proximal end 16 of thecatheter 12 and then transition to one or more different braid densitiesas the braided layer 40 approaches the distal end 14 of the catheter 12.The braid density at the distal end 14 may be greater or less than thebraid density at the proximal end 16. A catheter assembly having abraided layer with a varying braid density in described in U.S. patentpublication no. 2007/0299424, which is incorporated herein by referencein its entirety. In a specific example, the braid density at the base(i.e., proximal end 16) is about 50 PPI and the braid density at distalend 14 is about 10 PPI. In another embodiment, the braid density atdistal end 14 is about 20% to about 35% of the braid density at thebase/proximal end 16.

The braided layer 40 may be formed separately on a disposable core. Oneor more portions of the braided layer 40 may be heat tempered and cooledbefore incorporation into the catheter assembly 12 by methods that areknown to those of ordinary skill in the art. The action of heattempering may help to release the stress on the wire and help reduceradial forces. Alternatively, the braided layer 40 may be braideddirectly about the inner layer 20. A layer of heat shrink 60 mayoptionally be placed over the top of the outer layer 50. The heat shrinklayer 60 may comprise a fluoropolymer or polyolefin material.

FIG. 4 depicts the catheter assembly 12 after a lamination process. Thecatheter assembly 12 may be laminated by heating the catheter assemblyuntil the material comprising the outer layer 50 flows and redistributeswithin the catheter assembly 12. The heat shrink layer 60 has a highermelting temperature than the outer layer 50; therefore, during the meltprocess, the heat shrink layer 60 retains its tubular shape and forcesthe liquefied outer layer 50 material to redistribute throughout braidedlayer 40 (if present) and into the spaces between adjacent side lumens30 of inner polymeric layer 20. The catheter assembly 12 may then becooled. In FIG. 4, the mandrel 10 is still in place.

The mandrel 10 may be removed from catheter assembly 12, leaving behinda lumen 11 as illustrated in FIG. 5, which depicts a catheter 12 made inaccordance with the method of the present invention subsequent to theapplication of heat for the lamination process. If used, the smalldiameter mandrels (or set-up wires) 90 may also be removed from the sidelumens 30.

At least one elongate member 70 may be inserted through the side lumens30. The elongate members 70 may be used for a variety of purposes, forexample to provide steerability or deflectability or to conduct energyto energy delivery elements, including, for example, electrodes,ultrasound transducers or microwave elements. The elongate members 70may comprise a wide range of materials, including, but not limited to, ametallic material, such as a metallic wire, alloy or clad material, apolymer material, including conductive polymers, a composite material, afibrous material, such as high strength synthetic fibers made of highperformance engineering polymer materials (e.g., Kevlar® fibers and thelike), a resilient member, and a thread.

As one example, a flat pull wire may be used in accordance with thepresent invention. The flat pull wire may be made of stainless steel andis may be from about 0.002-0.008 inches by about 0.006-0.024 inches, orlarger. An example of a pull wire that is suitable for use with thepresent invention is described in U.S. patent publication no.2007/0299424, which has been incorporated herein by reference in itsentirety. A person of skill in the art will appreciate, however, thatother types of pull wires may be used with the present invention,including, for example, pull wires having circular or oval crosssections and pull wires made of clad metals or metal alloys. Inaddition, the pull wire 72 may also serve as the electrical wire 74, orseparate electrical wires may be used.

Optionally, the heat shrink layer 60 may be left in place around theouter layer 50, as depicted in FIG. 5, even after the mandrel 10 isremoved. If the heat shrink 60 is removed, the outer layer 50 becomesthe outermost layer of the catheter 12. The result is a substantiallycircular catheter 12 with multiple side lumens 30 integrally-formedwithin inner layer 20, each side lumen containing at least one elongatemember 70.

Catheter 12 may further include one or more pull rings (not shown) toprovide steerability. The pull wires are mechanically coupled to the oneor more pull rings according to known methods.

Another method of manufacturing the catheter 12 according to the presentinvention will be described with reference to FIGS. 6-9. In thisembodiment, an inner polymeric layer 120 and a multi-lumen layer 130 areco-extruded. FIG. 6 depicts the inner polymeric layer 120 afterco-extrusion with the multi-lumen layer 130. The inner polymeric layer120 includes an inner surface 102 defining a main lumen 110 and an outersurface 104. The multi-lumen layer 130 includes two or more side walls132 and each side wall 132 defines a side lumen 134. In one embodiment,the side walls 132 are spaced about the outer surface 104 of the innerpolymeric layer 120. In an alternate embodiment, the side walls 132 arespaced about the inner surface 102 of the inner polymeric layer 120. Theside walls 132 may be spaced symmetrically about the outer surface 104of the inner polymeric layer 120, but need not be in a symmetricalorientation.

The features of the side lumens 30 described above with reference toFIGS. 2A-2D, including the number, dimensions, shapes and orientation ofthe side lumens about the outer surface 15 of the main lumen 11 applyequally to the side lumens 134 comprising multi-lumen layer 130. Thus,the number, dimensions, shapes and orientation of the side lumens 134 inthe multi-lumen layer can be selected by a person of ordinary skill toaccommodate multiple elongate members of various sizes andcross-sectional configurations.

The inner polymeric layer 120 and the multi-lumen layer 130 may be madeof the same or different materials. In one embodiment, the innerpolymeric layer 120 and the multi-lumen layer 130 are extrudedpolytetrafluoroethylene (PTFE) tubing, such as Teflon® brand tubing,which is available commercially. The inner polymeric layer 120 mayoptionally be chemically etched to provide better adhesion during meltprocessing. As a person of skill in the art will appreciate, the innerpolymeric layer 120 may be made of other melt processable polymers. Inone aspect, the inner polymeric layer 120 is made of a material with amelting temperature higher than that of an outer layer 160, which willbe further described below, such that the inner polymeric layer 120 willwithstand melt processing of the outer layer 160.

FIG. 7 displays a cross-section of a catheter assembly prior tomelt-processing of the layers by heating. The inner polymeric layer 120and multi-lumen layer 130 are co-extruded. The co-extruded layers areplaced on mandrel 10. A small diameter mandrel or set-up wire 90 may beplaced within the side lumens 134 to maintain the integrity of the sidelumens during processing. Alternatively, a pull wire (FIG. 9) may beinserted through one or more of the side lumens 132 in lieu of a smalldiameter mandrel 90. In still other embodiments, the side lumens 132 maybe maintained during processing via the use of a pressurized fluid.

An outer polymeric layer 160 is then placed over the multi-lumen layer130. The outer polymeric layer 160 may be made of either single ormultiple sections of tubing that may be either butted together oroverlapped with each other. In one aspect, the outer polymeric layer 160is made of a melt-processable polymer, such as polyether block amides,nylon, polyethylene and other thermoplastic elastomers. For example, theouter polymeric layer 160 may be made of Pebax®, polyether block amidemade by Arkema, Inc. Pebax® of various durometers may be used,including, without limitation, Pebax 20D to Pebax 72D. The outerpolymeric layer 160 may also comprise more than one layer or segment,including for example two or more tubes of a melt processing polymerarranged to abut one another and/or to overlap one another.

Optionally, a braided layer 150 may be placed over the multi-lumen layer130 before the outer polymeric layer 160 is applied. The braided layer150 may have any of the characteristics described above with referenceto the braided layer 40 (FIG. 3). The braided layer 150 may be formedseparately on a disposable core. One or more portions of the braidedlayer 150 may be heat tempered and cooled before incorporation into thecatheter assembly by methods that are known to those of ordinary skillin the art. The action of heat tempering may help to release the stresson the wire and help reduce radial forces. A layer of heat shrink 170may optionally be placed over the top of the outer layer 160. The heatshrink layer 170 may comprise a fluoropolymer or polyolefin material.

FIG. 8 depicts the catheter assembly after a lamination process. Thecatheter assembly may be laminated by heating the catheter assemblyuntil the material comprising the outer layer 160 flows andredistributes within the catheter assembly. The heat shrink layer 170has a higher melting temperature than the outer layer 160; therefore,during the melt process, the heat shrink layer 170 retains its tubularshape and forces the liquefied outer layer 160 material to redistributethroughout braided layer 150 (if present) and around the side lumens 134of the multi-lumen layer 130. The catheter assembly may then be cooled.In FIG. 8, the mandrel 10 is still in place.

The mandrel 10 may be removed from catheter assembly 12, leaving behinda lumen 110 as illustrated in FIG. 9, which depicts a catheter 12 madein accordance with the method of the present invention subsequent to theapplication of heat for the lamination process. If used, the smalldiameter mandrels (or set-up wires) 90 may also be removed from the sidelumens 134 and at least one elongate member 122, such as a pull wire 124or electrical wire 126, may be inserted through the side lumens 134.

Optionally, the heat shrink layer 170 may be left in place around theouter layer 160, as depicted in FIG. 9, even after the mandrel 10 isremoved. If the heat shrink 170 is removed, the outer layer 160 becomesthe outermost layer of the catheter 12. The result is a substantiallycircular catheter 12 with multiple side lumens 134 co-extruded withinner polymeric layer 120, each side lumen containing at least oneelongate member 122.

Although multiple embodiments of this invention have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this invention. For example,person of skill in the art could modify inner polymeric layer 20 andmulti-lumen layer 130 to accommodate numerous combinations of pull wiresand electrical wires of various shapes and dimensions by modifying thenumber, size and orientation of the side lumens 30, 134 within theselayers.

All directional references (e.g., upper, lower, upward, downward, left,right, leftward, rightward, top, bottom, above, below, vertical,horizontal, clockwise, and counterclockwise) are only used foridentification purposes to aid the reader's understanding of the presentinvention, and do not create limitations, particularly as to theposition, orientation, or use of the invention. Joinder references(e.g., attached, coupled, connected, and the like) are to be construedbroadly and may include intermediate members between a connection ofelements and relative movement between elements. As such, joinderreferences do not necessarily infer that two elements are directlyconnected and in fixed relation to each other.

It is intended that all matter contained in the above description orshown in the accompanying drawings shall be interpreted as illustrativeonly and not limiting. Changes in detail or structure may be madewithout departing from the spirit of the invention as defined in theappended claims.

1-35. (canceled)
 36. A catheter assembly formed according to a processcomprising: co-extruding an inner polymeric layer of a first polymericmaterial and a multi-lumen layer of a second polymeric materialdifferent from the first polymeric material, wherein the inner polymericlayer defines a main lumen and the multi-lumen layer defines two or moreside lumens spaced about the main lumen, and wherein a size of the twoor more side lumens is less than a size of the main lumen; forming anouter polymeric layer about the co-extruded inner polymeric layer andmulti-lumen layer; and inserting at least one elongate member througheach of the two or more side lumens.
 37. The catheter assembly accordingto claim 36, wherein the two or more side lumens are spacedsymmetrically about the main lumen.
 38. The catheter assembly accordingto claim 36, wherein the multi-lumen layer defines between two andsixteen side lumens.
 39. The catheter assembly according to claim 38,wherein the multi-lumen layer defines between six and sixteen sidelumens.
 40. The catheter assembly according to claim 36, wherein thesize of the two or more side lumens is between ⅕ and 1/16 the size ofthe main lumen.
 41. The catheter assembly according to claim 1, whereinthe first polymeric material comprises polytetrafluoroethylene.
 42. Thecatheter assembly according to claim 36, wherein the process furthercomprises forming a braided layer between the outer polymeric layer onone side and the co-extruded inner polymeric layer and multi-lumen layeron another side.
 43. The catheter assembly according to claim 36,wherein the process further comprises heating the co-extruded innerpolymeric layer and multi-lumen layer and the outer polymeric layer tobond the co-extruded inner polymer layer and multi-lumen layer to theouter polymeric layer.
 44. The catheter assembly according to claim 36,wherein the at least one elongate member comprises at least one of apull wire and an electrical wire.
 45. A catheter assembly, comprising: aco-extrusion of an inner polymeric layer of a first polymeric materialthat defines a main lumen and a multi-lumen layer of a second polymericmaterial different from the first polymeric material that defines two ormore side lumens spaced about the main lumen, wherein a size of the twoor more side lumens is less than a size of the main lumen; an outerpolymeric layer disposed about the co-extrusion of the inner polymericlayer and the multi-lumen layer; and at least one elongate memberextending through each of the two or more side lumens.
 46. The catheterassembly according to claim 45, wherein the two or more side lumens arespaced symmetrically about the main lumen.
 47. The catheter assemblyaccording to claim 45, wherein the multi-lumen layer defines between twoand sixteen side lumens.
 48. The catheter assembly according to claim47, wherein the multi-lumen layer defines between six and sixteen sidelumens.
 49. The catheter assembly according to claim 45, wherein thesize of the two or more side lumens is between ⅕ and 1/16 the size ofthe main lumen.
 50. The catheter assembly according to claim 45, whereinthe first polymeric material comprises polytetrafluoroethylene.
 51. Thecatheter assembly according to claim 45, further comprising a braidedlayer disposed between the outer polymeric layer on one side and theco-extrusion of the inner polymeric layer and the multi-lumen layer onanother side.
 52. The catheter assembly according to claim 45, whereinthe at least one elongate member comprises at least one of a pull wireand an electrical wire.